Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047021
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2002-10-03
Brief Title:
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma
PURPOSE Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma
Detailed Description:
OBJECTIVES
Determine non-hematologic toxic effects of high-dose cytarabine and high-dose mitoxantrone in patients with recurrent or refractory leukemia or lymphoma
Determine the in vitro TNK lymphocyte proliferative responses to patients leukemialymphoma cells before and after treatment with this regimen
OUTLINE Patients receive high-dose cytarabine IV over 1 hour on days 1-5 and high-dose mitoxantrone IV over 15-30 minutes on day 5 Patients also receive sargramostim GM-CSF subcutaneously beginning on day 14 and continuing until blood counts recover
Patients who achieve at least stable disease or a response may receive a second course beginning at least 14 days after the first course is completed
Patients are followed for 3 months
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within approximately 2-3 years
Determine non-hematologic toxic effects of high-dose cytarabine and high-dose mitoxantrone in patients with recurrent or refractory leukemia or lymphoma
Determine the in vitro TNK lymphocyte proliferative responses to patients leukemialymphoma cells before and after treatment with this regimen
OUTLINE Patients receive high-dose cytarabine IV over 1 hour on days 1-5 and high-dose mitoxantrone IV over 15-30 minutes on day 5 Patients also receive sargramostim GM-CSF subcutaneously beginning on day 14 and continuing until blood counts recover
Patients who achieve at least stable disease or a response may receive a second course beginning at least 14 days after the first course is completed
Patients are followed for 3 months
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within approximately 2-3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASE-5Y01 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-5Y01 | None | None | None |
| NCI-G02-2113 | None | None | None |
| CWRU-11021P | None | None | None |